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WO2005121735A2 - Capteur de pression mecanique implantable et procede de fabrication dudit capteur - Google Patents

Capteur de pression mecanique implantable et procede de fabrication dudit capteur Download PDF

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Publication number
WO2005121735A2
WO2005121735A2 PCT/US2005/020244 US2005020244W WO2005121735A2 WO 2005121735 A2 WO2005121735 A2 WO 2005121735A2 US 2005020244 W US2005020244 W US 2005020244W WO 2005121735 A2 WO2005121735 A2 WO 2005121735A2
Authority
WO
WIPO (PCT)
Prior art keywords
pressure sensor
implantable mechanical
passive pressure
substrate
mechanical passive
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2005/020244
Other languages
English (en)
Other versions
WO2005121735A3 (fr
Inventor
Yu-Chong Tai
Ellis Meng
Po-Jui Chen
Damien C. Rodger
Mark Humayun
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
California Institute of Technology
Original Assignee
California Institute of Technology
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by California Institute of Technology filed Critical California Institute of Technology
Publication of WO2005121735A2 publication Critical patent/WO2005121735A2/fr
Publication of WO2005121735A3 publication Critical patent/WO2005121735A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B3/00—Apparatus for testing the eyes; Instruments for examining the eyes
    • A61B3/10—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions
    • A61B3/16—Objective types, i.e. instruments for examining the eyes independent of the patients' perceptions or reactions for measuring intraocular pressure, e.g. tonometers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L7/00—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements
    • G01L7/02—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges
    • G01L7/04—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges in the form of flexible, deformable tubes, e.g. Bourdon gauges
    • G01L7/045—Measuring the steady or quasi-steady pressure of a fluid or a fluent solid material by mechanical or fluid pressure-sensitive elements in the form of elastically-deformable gauges in the form of flexible, deformable tubes, e.g. Bourdon gauges with optical transmitting or indicating means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/028—Microscale sensors, e.g. electromechanical sensors [MEMS]

Definitions

  • the current invention is directed to an implantable optical pressure sensors; and more particularly to an implantable mechanical intraocular pressure sensor for passive measurement of the intraocular pressure and methods of manufacturing such sensors.
  • Glaucoma is a debilitating disease that results in loss of vision for an estimated 65 million people worldwide. Glaucoma is the second leading cause of blindness in the U.S. and the leading cause of preventable blindness. Yet, only half of the people with Glaucoma know they have the disease. Glaucoma is principally defined by damage to the optic nerve, the ultimate pathway for visual information after processing by the retina at the posterior aspect of the eye. Of the many risk factors for this optic neuropathy, perhaps the most significant is elevated intraocular pressure (IOP). Because IOP is strongly implicated in the pathogenesis of glaucoma, and because treatment involves lowering patients' IOP, methods of precisely monitoring real-time pressure changes are critical for treatment of this disease.
  • IOP intraocular pressure
  • MEMS pressure sensor designs In response to the deficiency of current measurement methods, many micromachined or "MEMS" pressure sensor designs have been proposed. MEMS devices are of interest because in principal the small scale of MEMS devices allows for the implantation of a sensor for constant IOP monitoring. These microfabricated devices can provide accurate and precise pressure readouts, but conventional designs all require electrical circuitry and hermetic sealing, a significant impediment to their implementation. None of the IOP sensors proposed solve the two principal difficulties of these devices; power consumption and biocompatibility. Accordingly, an improved sensor for providing faithful IOP measurement inside the eye without the twin problems of power consumption and biocompatibility is needed.
  • the current invention is directed to a passive, biocompatible micromachined pressure sensor comprising a micromachined curved tube that contracts and expands in response to changes in pressure.
  • the sensor comprises an implantable micromachined Bourdon tube.
  • the sensor can be implanted under the cornea so that IOP changes can be constantly monitored.
  • the sensor in accordance with the current invention can be measured passively through optical inspection of the device using standard ophthalmologic equipment, such as stereoscopes and magnifiers.
  • the sensor in accordance with the current invention has a 1 mmHg resolution and a ⁇ 6 mmHg dynamic range.
  • the invention is directed to a method of manufacturing a sensor in accordance with the current invention.
  • the sensor is made using standard micromachining techniques in a simple two mask process.
  • the sensor in accordance with the current invention is formed of a USP Class VI biocompatible material.
  • the biocompatible material is pure parylene or has a parylene coating.
  • FIG. la provides a schematic view of a Bourdon tube sensor in accordance with one exemplary embodiment of the current invention.
  • FIG. lb provides a schematic view of an enlarged cross-sectional view of the Bourdon tube sensor shown in FIG. 1 a.
  • FIG. 2 provides a schematic perspective view of an intraocular pressure in accordance with the current invention and its relative motion with increasing and decreasing pressure.
  • FIG. 3 shows SEM micrographs (stereoscope image in FIG. 3 a and microscope image in FIG. 3b) of a micromachined sensor in accordance with one embodiment of the current invention.
  • FIGs. 4a to 4c provide graphical plots of data on the relative motion of exemplary embodiments of intraocular pressure sensors in accordance with the current invention under changing pressure conditions.
  • FIGs. 5a to 5f show microscope micrographs of various bent tube configurations for pressure sensors in accordance with additional embodiments of the current invention.
  • FIGs 6a and 6b show schematic diagrams of spiral-type pressure sensors having large moment arms in accordance with another embodiment of the current invention.
  • FIGs. 7a and 7b show schematic diagrams of a compact linear-type pressure sensor in accordance with another embodiment of the current invention.
  • FIG. 8 shows a schematic diagram of the process flow for an embodiment of a method for manufacturing the pressure sensor of the current invention.
  • FIG. 9a and 9b show microscope micrographs of trenches at different stages of formation in accordance with the method of the current invention.
  • FIG. 10 shows an microscope micrograph of a pressure sensor formed in accordance with the method of the current invention.
  • FIG. 11a and l ib provide microscope micrographs showing details of trenches formed in accordance with the methods of the current invention.
  • FIG. 12 shows a schematic of a measurement apparatus for use with the current invention.
  • FIG. 13a shows a stereoscope micrograph of an array of pressure sensors formed in accordance with the current invention for operation in air.
  • FIG. 13b shows a graphical plot of data taken from pressure measurements obtained in air using the pressure sensors shown in FIG. 13 a.
  • FIG. 14a shows a microscope micrograph of an array of pressure sensors formed in accordance with the current invention for operation in EPA.
  • FIG. 14b shows a graphical plot of data taken from pressure measurements obtained in EPA using the pressure sensors shown in FIG. 14a.
  • FIG. 15a shows a microscope micrograph of an array of pressure sensors formed in accordance with the current invention for operation in water.
  • FIG. 15b shows a graphical plot of data taken from pressure measurements obtained in water using the pressure sensors shown in FIG. 15 a.
  • the current invention is directed to a passive, biocompatible micromachined pressure sensor comprising a micromachined curved tube that contracts and expands in response to changes in pressure, hereinafter referred to as an "implantable sensor” or simply “sensor.”
  • the implantable sensor of the current invention is inspired by a common pressure gauge called the Bourdon tube.
  • a Bourdon tube is a toroidal, elastic shell with thin walls, oval cross section, and with closed ends. (Schematic diagrams of a Bourdon tube are provided in FIGs la and lb.) As shown in FIG.
  • the curvature of the center line of the tube changes proportionally with the applied wall pressure. Measurements of the resultant motion of one end of the tube with reference to the other may then be interpreted, after appropriate calibration, as pressure measurements.
  • the current invention recognizes that micromachined Bourdon tubes and other tubular curved closed-ended structures may be used as implantable pressure sensors for IOP applications.
  • the sensor 10 of the current invention takes the shape of a standard Bourdon tube, i.e., a high-aspect-ratio 3-D free- standing Archimedean spiral 11, with closed ends 12 and 14.
  • the central part of the device is a cylinder 16 fixed to a substrate 18 which also keeps the device fixed.
  • the device may also be provided with measurement fiducials 20 on the outside aspect to provide a more easy optical measurement of the relative motion of the outer end 14 of the sensor.
  • the fixation of the device on the substrate is of added importance so that the end 14 of the sensor is kept in register with the fiducials 20.
  • a micrograph of a Bourdon tube-type sensor in accordance with the current invention, including the measurement fiducials is shown in FIG. 3.
  • the mechanism of the sensor of the current invention relies on the phenomenon that, when the pressure inside a closed flexible bent structure that has been fixed to the surface at one end, such as the Bourdon tube shown in FIG.
  • R is the varying curvature, in which R max and R mm are maximum and minimum curvatures of the spiral
  • ⁇ is the coiled angle of the spiral
  • t, 2w, 2h are wall thickness, width, and height of the hollow elliptical structure, respectively.
  • ⁇ P is the pressure difference between the inside and outside of the tube
  • E is the Young's modulus
  • v is Poisson's ratio
  • C and C 2 are constant coefficients from Table 1 , below.
  • Pa pressure difference using several different designs of sensors incorporating Bourdon tubes having different critical dimensions. Some of the geometrical features are intentionally chosen to indicate the limitations of the state-of-the-art micromachining process.
  • the sensitivity of the various design and the control of the level of displacement are also plotted in Figs. 4a to 4c, which show the u r for a 1 mmHg pressure difference (4a), the U ⁇ for a 1 mmHg pressure difference (4b), and ⁇ P-u ⁇ (4c), respectively.
  • simply varying the relative dimensions of the body of the sensor can be used to tune the sensitivity of the sensor, and the size of the indicating dis lacement of the sensor of the current invention.
  • FIGs. 5a to 5f show a variety of bent close-ended hollow bodies that could be utilized as pressure sensors in the current invention. These vary from simple hook designs (5a) to full spiral tubes (5f). These embodiments are provided to emphasize that the number and type of turns is not critical to the operation of the current invention.
  • the fixed end of the sensor need not be located central to the curved body, but can also be located at the outer end of the curved body such that the movement occurs in the interior of the sensor body.
  • the only requirements are at least one bent flexible portion of a tube 22 having two closed ends, a first end fixed to a substrate 24 and a second end 26, which is free to move in response to a pressure change.
  • other modifications to the sensor may be made, such as lengthening the indicator portion 28 at the free end of the sensor body 30 such that even minor movements of the bent tube produce very large displacements at the far end 32 of the sensor body.
  • an even more sensitive arrangement would involve the disposition of two of the extended sensors of FIG.
  • FIG. 6a in opposition to one another, such that the two indicator portions 34 and 36 would move in opposite directions one from the other in response to a pressure change, effectively doubling the sensitivity of the single extended arm pressure sensor of FIG. 6a.
  • An SEM micrograph of such an opposing tip sensor formed in accordance with the current invention is provided in the inset to FIG. 6b.
  • one end of the curved section at one end of the zigzag structure is fixed to the substrate 40 and the remaining sections are free to move, such that a change in pressure imparts a linear motion 42 in the series of bent tubes (see, e.g., FIG. 7b).
  • a change in pressure imparts a linear motion 42 in the series of bent tubes (see, e.g., FIG. 7b).
  • the concept of the device is based on a Bourdon tube, but only requires that the pressure inside a hollow bent body is sealed at a designated constant, such that when a uniform pressure difference is generated across the channel walls, a bending moment is created in opposition to a fixed end of the body that in turn forces an in-plane radial and angular deformation of the hollow body.
  • the deformation which can be visualized by movement of the free end of the hollow body, is linearly related to the pressure difference. Therefore, the corresponding environmental (outside-wall) pressure can be measured.
  • the remaining aspects of the geometry depend principally on design considerations, such as preventing out-of-plane deformation, and the sensitivity required for the desired application.
  • the angular deformation indicated by the tip rotation can be amplified by increasing the number of coiled turns or increasing the length of the indicator arm of the free tip.
  • a channel structure with thinner walls and higher aspect-ratio profile is more sensitive to environmental pressure change. In any application, each of these design factors must be considered to achieve the desired pressure sensitivity of the device.
  • FIG. 8 shows a schematic flow-chart for one exemplary manufacturing method
  • FIGs. 9a and 9b shown SEM micrographs of cross-sections of the hollow body made in accordance with the current invention during various stages of the process.
  • the fabrication process begins with 5000 A wet oxidation on a standard silicon wafer (8a). After patterning the oxide (see inset of FIG. 8a), a conventional Bosch process in a PlasmaTherm DREE is used to etch trenches (8b). SF 6 plasma etching is then performed to isotropically undercut the silicon surrounding the trenches. 75 ⁇ m deep, 6 ⁇ m wide trenches with 2.5 ⁇ m sidewall undercut can be created by using the above process (see inset to FIG. 8b and microscope micrograph of FIG. 9a). Before parylene deposition, a short C F 8 deposition is performed to intentionally degrade the adhesion between the silicon and the parylene.
  • a 5 ⁇ m thick parylene layer is deposited (8c).
  • This conformal deposition concurrently seals the trenches to form the spiral channel (see inset to FIG. 8d and microscope micrograph of FIG. 9b), the pointing tip, the surrounding indicators, and a parylene "web" structure at the center that supports the channel.
  • the parylene is then patterned by using oxygen plasma (8d and see inset of FIG. 8d). During this step, a thin opening ring is created in the center to prevent the complete sealing of the device.
  • the spiral channel is released from the substrate by XeF 2 gaseous etching (8e). A fabricated device with a radius of 1 mm is shown in FIG. 10.
  • the radius of the central supporting cylinder is 100 ⁇ m.
  • the spiral channel ends at a 100 ⁇ m long, 6 ⁇ m wide pointing tip (shown in detail in the inset to FIG. 10), and the rotation angle can be optically recorded from 5 degree/division indicators surrounding the device. Because the sensor device is still open to environmental pressure, a photoresist drop is dispensed over the central cylinder and dried to seal the channel at a controllable pressure. At the current phase of development, the device is sealed at 1 atm as the gauge reference. Ideally, the undercut surrounding the etched trenches should be isotropic.
  • one embodiment of a method of forming a pressure sensor in accordance with the current invention involves the following steps:
  • a biocompatible material such as parylene (poly-para-xylylene) is selected.
  • Parylene is an ideal structural material for implantable sensors because of its desirable properties, such as high flexibility (Young modulus ⁇ 3 GPa), chemical inertness, and biocompatibility.
  • parylene is compatible with microfabrication technology and can be deposited as a pinhole-free conformal coating at room temperature. It has been widely used in microfluidic and bioMEMS devices. Recently, the micromachining techniques and applications of high- aspect-ratio parylene structures have been successfully demonstrated.
  • a device such including the pressure sensor according to the invention may also include a body, and any additional machinery or circuitry necessary for the device's operation.
  • the body of the pressure sensor itself can be made of any material suitable for micromachining utilizing standard lithographic or MEMS techniques to enclose the micro structure, such as, for example, aluminum, silicon, or silicon dioxide.
  • the body further comprises a cap layer, which can be of any design, such that the cap layer protects the sensor from unwanted contact with the external environment.
  • a cap layer could be made of any suitable material, such as, for example, a polymer (including but not limited to parylene, PDMS, or polyimide), aluminum, silicon dioxide, or silicon.
  • a cap layer could be formed by any conventional MEMS process, such as growth or deposition over a sacrificial layer (not shown) deposited to encapsulate the pressure sensor wherein the sacrificial layer can subsequently be removed to expose the sensor itself.
  • these support structures could be formed in a single deposition step with the pressure sensor.
  • one of the substrate, the cap layer, or walls of the sensor is transparent such that the optical source can be used to interrogate the sensor.
  • the invention can be better understood with reference to the following non-limiting examples.
  • the testing setup used in the following examples is illustrated in FIG. 12.
  • a system consisting of an N 2 gas cylinder, a particle filter, an Airtrol R-800-60 pressure regulator, and two needle valves is used to regulate the pressure. One needle valve releases the applied pressure after each measurement.
  • This system is connected to a closed chamber to provide different positive-applied pressures.
  • the cap of the chamber is transparent to facilitate external optical observation.
  • a device with a 10-turn spiral is placed inside the chamber and tested (inset to FIG. 12). When a pressure difference is applied between the outside and the inside of the channel, the pointing tip starts to rotate.
  • the resulting pressure-rotation relationship of the sensor of the current invention in isopropyl alcohol (EPA) is plotted in FIG. 14b, and remains a linear response. Under this condition, tip rotation is continuous with pressure changes, and the sensitivity in EPA is also improved from that in air. En the pressure range of 6 psi, the measured sensitivity has an average of 0.22 degree/mmHg, with ⁇ 9% variation in specific rotation angles. Finally, the sensor of the current invention was also tested in water, which is most comparable to the saline medium of interest in IOP sensing applications. When first immersed in water, the device was not functional because the hydrophobic parylene surface induces formation of bubbles on the surface of device.

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measuring Fluid Pressure (AREA)

Abstract

L'invention concerne un capteur de pression micro-usiné, mécanique, biocompatible, ainsi que des procédés de fabrication dudit capteur de pression. Le capteur de pression selon la présente invention comprend une structure tubulaire courbe à rapport largeur/longueur élevé fabriquée à l'aide d'un procédé de dépôt de parylène monocouche. Le capteur de pression selon la présente invention ne consomme pas d'énergie et indique la variation de pression par des changements du mouvement dans le plan in situ du capteur, laquelle peut être mesurée de l'extérieur par une observation optique directe et commode. Dans un mode de réalisation, le capteur de pression selon la présente invention peut faire office de capteur de pression intra-oculaire (PIO) destiné à être implanté dans l'oeil, le mouvement dans le plan intra-oculaire du capteur pouvant être enregistré depuis l'extérieur de l'oeil, de sorte que la pression intra-oculaire chez des patients atteints de glaucome peut être surveillée de manière constante.
PCT/US2005/020244 2004-06-07 2005-06-07 Capteur de pression mecanique implantable et procede de fabrication dudit capteur Ceased WO2005121735A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US57805204P 2004-06-07 2004-06-07
US60/578,052 2004-06-07

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WO2005121735A2 true WO2005121735A2 (fr) 2005-12-22
WO2005121735A3 WO2005121735A3 (fr) 2006-11-23

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US (1) US7252006B2 (fr)
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